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CompletedNCT01868152Updated Mar 22, 2016

The Realtime Detection for Prediction of Opioid Analgesic

An observational study in Surgery and Individuality, sponsored by Huazhong University of Science and Technology. Completed at 1 site in China. Open to female participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-03-22.

Sponsored by Huazhong University of Science and Technology · Observational

Study type
Observational
Model
Cohort
Enrollment
131
Ages
20 Years to 65 Years
Sex
Female
01

Study summary

This study aimed to find a quick and timely way to predict the individual variation of efficacy of opioid analgesic during the operation and postoperative analgesia in Chinese patients undergoing elective surgeries. Methods: female patients receiving elective surgery under general anesthesia were recruited into this study. At the time of routine intravenous anesthetic induction we observe the efficacy of opioid analgesic including analgesic effect, effects on Narcotrend index, sedative effect, effects on respiratory system, and aslo effects on cardiovascular system. Then we record the consumption of of opioid analgesic during the operation and postoperative analgesia. Also we record the side effect of the opioid analgesic.

Read the detailed description

Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.

02

Conditions studied

  • Surgery
  • Individuality

Keywords

  • sufentanil
  • individual variation
  • pain threshold
  • narcotrend index
03

In context

Lead sponsor

Huazhong University of Science and Technology is the lead sponsor of 241 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Chinese female patients receiving elective surgery under general anesthesia

Eligibility criteria

Inclusion Criteria:

  • Aged 20-65 years
  • Anesthesiologists (ASA) physical status I or II;
  • Within ±20% of ideal body weight;
  • Agreed to participate the research

Exclusion Criteria: •History of chronic pain;

  • Psychiatric diseases;
  • Diabetes mellitus;
  • Severe cardiovascular diseases;
  • Kidney or liver diseases;
  • Alcohol or drug abuse (according to the criteria of DSM-IV);
  • Pregnancy or at lactation period;
  • Disagree to participate to the research
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Study design

Observational model
Cohort
Enrollment
131 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Rangeability of pressure pain threshold

    According to the measurement of pressure pain threshold before and after intravenous injection of opioid analgesics

    Time frame: 8 months

Secondary outcomes

  1. Rangeability of Narcotrend index

    According to the measurement of Narcotrend index before and after intravenous injection of opioid analgesics

    Time frame: 8 months

  2. Rangeability of Ramsay Sedation Scale

    According to the investigation of Ramsay Sedation Scale before and after intravenous injection of opioid analgesics

    Time frame: 8 months

  3. Rangeability of respiratory frequency

    According to the measurement of respiratory frequency before and after intravenous injection of opioid analgesics

    Time frame: 8 months

07

Study locations

1 site
  • Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430030, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01868152
Lead sponsor
Huazhong University of Science and Technology
Responsible party
Xianwei Zhang (Professor, MD., Huazhong University of Science and Technology) — Principal investigator
First posted
Jun 4, 2013
Start date
Apr 2013
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Mar 22, 2016

Study contacts

Zhang Xianwei, MD
study director · Huazhong University of Science and Technology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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